Nyxoah SA Q4 FY2025 earnings call

• 2025 was a transformative year for Nixoa. Early in 2025, the U.S. commercial team was hired and trained. On August 8, 2025, US FDA approval for Genio was received, followed by active launch. Reimbursements for Genio across Medicare and commercial payers were secured, resulting in $4.5 million of revenue generated in Q4. 145 surgeons were trained in 125 high-volume hypoglossal nerve stimulation accounts. The DREAM Pivotal study was published. Internationally, growth was seen in selected markets like Germany, UK, and the Middle East.
• Fourth quarter marked the first full quarter of U.S. commercialization. As of December 31, 2025, 25 sales reps focused on 125 out of 400 top AGNS accounts, 145 surgeons were trained, 120 Value Analysis Committee submissions were made with 57 approvals, and US reimbursement was consistent for Medicare and commercial payers.
• 2026 priority is to continue executing on the U.S. commercial launch. The salesforce was increased by 15 sales reps and 3 sales directors in Q1 2026, bringing total to 40 sales reps. Looking forward to 12-month excess study data on complete concentric collapse and subsequent PMA supplement submission potentially leading to US label expansion in early 2027. Expanding internal manufacturing footprint to strengthen competitive position and improve gross margins.

Fourth quarter of 2025: Gross revenue was 6.3 million euros before 700,000 of revenue deferrals, resulting in net revenue of 5.6 million euros compared to 1.3 million in the fourth quarter of 2024. This growth was driven by the U.S. commercial launch, which resulted in approximately 3.5 million euros of net revenue in the fourth quarter of 2025. Full year 2025: Gross revenue was 11 million euros before 1 million of revenue deferrals mainly due to disposable patches, resulting in net revenue of 10 million euros compared to 4.5 million in 2024, or 122% year-over-year growth. The U.S. is the primary growth driver, and international markets continue to provide a consistent revenue contribution.

Expect U.S. net revenue for both the first and second quarters of 2026 to grow 25% sequentially. International revenue is expected to follow typical seasonal patterns. Cash burn is approximately $20 million per quarter in the near term, and will decrease as U.S. revenue traction grows.

Statements relating to expectations or predictions of future events are forward-looking statements, involving material risks and uncertainties that could cause actual results or events to materially differ from those anticipated. Refer to the risk factors section of Form 20F for associated risks.

And our first question comes from the line of Adam Meader from Piper Sandler.

Q: Just on some of the leading indicators or metrics shared, with 120 VAC submissions made as of December 31st last year and 57 accounts activated, bridge on remaining VAC processes and when to expect more accounts to go active, and funnel for new accounts.

A: 120 VAC submissions made, 57 approved, remaining will start being approved during Q1. Sales force increased to 40, with 15 additional sales reps adding 75 additional accounts, covering 200 out of 400 high-volume accounts during Q1 and Q2. Next question from John Block from Stiefel.

Q: On cash burn rate and thoughts on pursuing own code and implant number.

A: Cash burn is approximately $20 million per quarter in near term. On pursuing own code, following the same pathway as competition, expecting dedicated coding for Genio likely beginning 2028. On implant number, no policy of putting products on the shelf, when training surgeons, provide implants based on pre-identified patients with backup. Next question from Suresh.

Q: On competitors' approach and key driver for Genio in sites.

A: Not loading shelves, implanting patients. Surgeons choosing Genio due to optionality, single incision technique, and bilateral quality of airway opening. Next question from David Riscott from Baird.

Q: On assumptions and guidance around new account ads, OPEX and gross margin guidance, and where patients are coming from.

A: Focused approach with salesforce reaching 200 accounts by end of Q1. Gross margin to increase slightly in 2026 due to increased sales volume, major step function up in 2027 with new generation disposable patch. R&D expense to go down sequentially in 2026. SG&A main driver is U.S. sales expansion. Patients are referred to surgeons in high volume accounts, appealed by Genio's design.